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Tuberculosis & Cardiology Projects

Tuberculosis & Cardiology Projects. Anita Walden & Brian McCourt RCRIM Presentation HL7 WGM January 2007 (San Diego). Topics. Background, Objectives, Methodology Project specific details Tuberculosis Project Cardiology Project Questions & Discussion. Background & Project Objectives.

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Tuberculosis & Cardiology Projects

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  1. Tuberculosis & Cardiology Projects Anita Walden & Brian McCourt RCRIM Presentation HL7 WGM January 2007 (San Diego)

  2. Topics • Background, Objectives, Methodology • Project specific details • Tuberculosis Project • Cardiology Project • Questions & Discussion

  3. Background & Project Objectives • Funded by two independent NIH Roadmap contracts • Focus on methodology for developing therapeutic area data standards • Produce real, useful products along the way • Report on experience, process, best practices back to the larger community

  4. Products • Develop and/or contribute to data exchange standards within SDOs (HL7, CDISC…) • Implementation Guide • Publish consensus set of Common Data Elements (CDE’s) • Generate a Domain Analysis Model • including storyboards, use cases and activity diagram artifacts

  5. Assumptions • Data collected for patient care must support multiple re-uses, including research • Clinical data for patient care and research are the same. • Stakeholders need to represent as many of the uses of the data as possible • Clinicians, researchers, standards organizations, industry, international…

  6. Methodology • Engage stakeholders in objectives • Select a use case from stakeholder contributions to define specific project scope and objectives • Develop a consensus set of CDE’s used in use case • Use case and CDE’s guide DAM development • Incorporate interchange standards under the DAM

  7. CDE Process • Collect & aggregate data elements from stakeholders current databases • Convene expert group to select ‘Package 1’ and focus on terminology, definitions, value lists • Clinical leadership at core of group, supported by experts from CDISC, NCI, HL7… • Biweekly conference calls • Release for public comment • Publish via NCI EVS/caDSR

  8. DAM Process • Start with pretty good understanding of storyboards, activity diagrams, use cases and CDE’s to set scope • Work with experienced modeler • Vetted by stakeholders • A use of DAM, provide context (associations) for Data Elements that will be provided to NCI’s caDSR.

  9. Timelines

  10. World Health Organization Stop TB Partnership DOT DOT Plus Center for Disease Control and Prevention (CDC) TIMS– Meta data NEDSS – Meta data RVCT - forms MOXI Brazil CRF forms TB Alliance TBESC - forms TBTC Study 26 – Meta data TBTC Study 27 – forms Data Element Contributors

  11. Clinical focus Pulmonary Tuberculosis Use Case Use data from EHR and public health reporting to trigger notification to researcher of potential study candidate Development of standard CRF modules for tuberculosis research projects Scope

  12. Single Source for Data Reuse and InteroperabilityPatient Enrollment/Aggregated Data Research Local Health Dept Query (message V2.5) Query (message V 2.5) Hosp.EHR Researcher State Health Dept Query (message V 2.5) Federal Health Dept Enrollment Data Aggregation Patient Treatment/Surveillance

  13. Aereas Global TB Vaccine Foundation Center for Disease Control and Prevention (CDC) Clinical Data Interchange Standards Consortium (CDISC) Clinical research experts Duke University Medical Center Foundation for Innovative New Diagnostics (FIND) Expert GroupRepresented Organizations • Global Alliance for TB Drug Development • KNCV • Health Level 7 (HL7) • National Cancer Institute • National Heart, Lung & Blood Institute (NHLBI) • National Institutes of Health (NIH) • National TB Controllers Association • WHO’s Stop TB Partnership • Pharmaceutical Companies

  14. Draft of CRF modules using current TB package #1 data elements. WHO is aware of the initiative TBTN needs to engage pharmaceutical companies in the process Continue to engage the global communities Challenges Languages Time Zones Country Resources TB not high priority in US Much of the work is International Technology is limited in many countries Additional Funding to continue TB Specifics

  15. Creating, Implementing, and Sharing Best Practices for Clinical Trials Networks This project has been funded in whole or in part with federal funds from the National Institutes of Health, under contract No. HHSN268200425212C, "Re-Engineering the Clinical Research Enterprise."

  16. American Heart Association Get With the Guidelines Society of Thoracic Surgeons NIH (NHLBI) GlaxoSmithKline Merck Data Element Contributors • American College of Cardiology National Cardiovascular Data Registry (NCDR) • CRUSADE • Duke Databank • Eli Lilly • European Society of Cardiology Cardiac Registry and Registration Standards (CARDS)

  17. Professional Societies & Clinical Organizations Am. College of Cardiology (ACC) Am. Heart Assoc. ACC/AHA Task Force on Data Standards Assoc. of Italian Hospital Cardiologists European Soc. Cardiology Soc. Cardiovascular Angiography & Intervention Society of Thoracic Surgeons Government FDA NIH (NCI, NCRR, NHLBI) VHA Expert Group - Represented Organizations • Standards Organizations • HL7 & HL7 Cardiology SIG • CDISC (incl. pharma) • Integrating the Healthcare Enterprise • Industry & Academia • AstraZeneca • GE • Leuven Coordinating Centre • Mortara • UCLA

  18. Scope • Clinical focus • Acute ischemic heart disease/Acute Coronary Syndromes (ACS) • Use Cases • A clinical site reporting data to a quality improvement registry (also IHE RFD use case) • HL7 CDA • A research study sending data to another organization or for regulatory submission • CDISC SDTM

  19. Status of related standards work • HL7 CDA • 1st draft mapping of ACC NCDR to HL7 CDA completed • To do – 1st draft Implementation Guide • Get feedback on work from HL7 groups • CDISC SDTM • 1st draft in development mapping of ACC NCDR to SDTM • Need to understand relationship to BRIDG and HL7 efforts

  20. Pilots • ‘Multiple data re-use’ pilot for future • Implement the draft HL7 CV CDA for reporting data to the ACC’s NCDR registry and to SDTM model • ‘Single Source’ clinical trial • Use existing HL7 messaging to report data directly to a large international phase III trial electronic data capture system.

  21. Discussion • All feedback & comments welcome • Domain Analysis Model: How should a clinical domain DAM relate to other models (i.e. BRIDG, Detailed Clinical Models (DCM)? • eDCI Message: What should we know in relation to these projects? • SDTM & HL7 v3: Work related to the cardiology SDTM-CDA piece to know about? • CDE’s & EVS/caDSR: Work related to TB standard CRFs to know about? • Other?

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